Identity
- Trade Name
- HomeSleepTest EUDAMED
- Model / Reference
- HomeSleepTest EUDAMEDHST Sensor EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413402762 EUDAMED
- Basic UDI-DI
- 42504134HSTRW EUDAMED
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HomeSleepTest by SOMNOmedics AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504134HSTRW | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (1)
- EUDAMED 74dc71aa-bff4-4073-a16c-61b9a6fc1e96 61 fields · synced Jun 19, 2026